Prevention of Seroma Following Inguinal Lymph Node Dissection With Prophylactic Incisional Negative Pressure Wound Therapy

Inguinal lymph node dissection (ILND) is indicated following metastatic malignant melanoma, and is associated with a high-complication rate, of which many begin with the formation of seroma and ends in complicated wound healing, reoperation, multiple outpatient visits and re-hospitalization. Prevention of seroma may therefore lead to a reduction of many of the preceding complications and improve patient quality-of-life. The aim of this study is to evaluate the efficacy and oncological safety of prophylactic negative pressure wound therapy following ILND in melanoma patients.

Study Overview

• Status: Terminated
• Conditions: Quality of Life; Lymphedema; Surgical Site Infection; Seroma
• Intervention / Treatment: Device: Negative pressure wound therapy; Other: Micropore tape

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark
    • Dept. of Plastic Surgery, Herlev Gentofte Hospital
  • København, Denmark
    • Dept. of Plastic Surgery, Rigshospitalet
  • Odense, Denmark
    • Dept. of Plastic Surgery, Odense University Hospital
  • Roskilde, Denmark
    • Dept. of Plastic Surgery, Roskilde Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All malignant melanoma patients who are candidates for ILND and 18 years of age or older

Exclusion Criteria:

• Patients suspected of having tumor residuals after ILND, previous groin irradiation or patients suffering from dementia or any psychiatric disorder making them incapable of informed consent or adherence to follow up, along with patients who are unable to communicate in Danish or English will not be included in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Negative pressure wound therapy	Device: Negative pressure wound therapy; Wound dressing; Other Names: vacuum assisted closure
ACTIVE_COMPARATOR: Control; Micropore tape	Other: Micropore tape; Wound dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with seroma	One or more inguinal seroma(s) which require aspiration	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of seromas for each participant	Number of aspirated seromas (No.)	3 months
Volume of seromas for each participant	Volume of aspirated seromas (mL)	3 months
Number of participants with surgical wound infection	Inguinal wound infection which require antibiotic treatment	3 months
Number of participants with wound rupture	Inguinal wound rupture which require addition suturing or NPWT treatment	3 months
Number of participants with wound necrosis	Inguinal wound necrosis which require debridement	3 months
Number of participants with hematoma	Inguinal wound hematoma which require evacuation	3 months
Questionnaire EQ-5D-5L	Quality of life measurement score	Baseline, 3 months and 2 years
Hospitalization time	Length of hospital stay until discharge (days)	3 months
Hospitalization readmission time	Length of hospital readmissions (days)	3 months
Number of participants with reoperations	Re-operation with opening of the wound or scar under general anesthesia due to adverse complications	3 months
Number of participants with lymphedema	Clinical evaluation using the International Lymphedema Society staging	2 years
Questionnaire LYMQOL	Lymphedema quality of life measurement score	2 years
Number of participants with regional recurrence	Histological verified recurrence to the inguinal site	2 years

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Study Chair: Jens A Sørensen, Department of Plastic Surgery, Odense University Hospital

Publications and helpful links

General Publications

• Jorgensen MG, Toyserkani NM, Thomsen JB, Sorensen JA. Surgical-site infection following lymph node excision indicates susceptibility for lymphedema: A retrospective cohort study of malignant melanoma patients. J Plast Reconstr Aesthet Surg. 2018 Apr;71(4):590-596. doi: 10.1016/j.bjps.2017.11.026. Epub 2017 Nov 28.
• Jorgensen MG, Chakera AH, Holmich LR, Drejoe JB, Andersen PCL, Khorasani H, Toyserkani NM, Thomsen JB, Sorensen JA. Can prophylactic incisional negative pressure wound therapy Reduce Wound Complications After Inguinal Lymph Node Dissection for Melanoma? Results from a Randomized Controlled Trial. JPRAS Open. 2022 Aug 26;34:134-143. doi: 10.1016/j.jpra.2022.08.003. eCollection 2022 Dec.
• Jorgensen MG, Toyserkani NM, Hyldig N, Chakera AH, Holmich LR, Thomsen JB, Sorensen JA. Prevention of seroma following inguinal lymph node dissection with prophylactic, incisional, negative-pressure wound therapy (SEROMA trial): study protocol for a randomized controlled trial. Trials. 2018 Aug 15;19(1):441. doi: 10.1186/s13063-018-2757-6. Erratum In: Trials. 2018 Oct 19;19(1):570.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ACTUAL): September 1, 2020
• Study Completion (ACTUAL): September 1, 2020

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (ACTUAL): February 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Lymphatic Diseases; Inflammation; Postoperative Complications; Wound Infection; Lymphedema; Surgical Wound Infection; Seroma
• Other Study ID Numbers: S-20170085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No